Chemotherapy, Radiation Therapy and Immunotherapy Prior to Surgery in Operable Esophageal Cancer

SCRI Development Innovations

Status and phase: Completed; Phase 2

Conditions: Esophageal Cancer

Treatments: Procedure: Radiation therapy; Drug: Paclitaxel; Drug: Erlotinib; Drug: Bevacizumab; Drug: Carboplatin; Procedure: Surgery; Drug: 5-FU

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00393068

SCRI GI 91

Details and patient eligibility

About

The purpose of this study is to see if adding two targeted drugs (bevacizumab and erlotinib) further improves the response to chemotherapy (5-FU, paclitaxel, carboplatin) and radiation therapy in patients with operable esophageal cancer.

Side effects (toxicity) information will also be collected.

Full description

Surgical removal has been the standard treatment for operable esophageal cancer. However, recent studies have shown improved results when patients receive a short course of chemotherapy and radiation therapy prior to surgery.

Prior to surgery study treatment will be given over a 6 weeks (Days 1-42) period. Beginning Day 1 and continuing through Day 35 patients will receive a continuous infusion of 5-FU by vein. A small portable pump will be used to administer this drug into a tube that has been surgically inserted into the patient's vein. On Day 1 and 22 patients will also receive the drugs paclitaxel, carboplatin and bevacizumab by vein. Erlotinib is given by mouth beginning on Day 1 and continuing through Day 45. Patients will receive radiation therapy daily, Monday through Friday, beginning Day 1-35 (approximately 5 weeks).

Surgery will be performed approximately 12-14 weeks after beginning this combined treatment.

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinically confirmed esophageal or gastroesophageal junction cancer stage I, II or III
• No prior treatment for esophageal cancer
• Must be surgical candidate based on stage and location of disease
• Measurable or evaluable disease
• Able to be up and perform self care
• Adequate liver, renal function and bone marrow function
• Patients will have to have a central venous access device placed
• Able to give written informed consent.
• Age 18 or older

Exclusion criteria

• Stage IV disease
• Prior cancer treatment for advanced cancer in the last 5 years
• Pregnant or lactating women
• History of stroke, transient ischemic attacks, or acute MI within the past 6 months or any other serious cardiovascular disease
• History of neurological disease
• Recent history of blood in the sputum or vomitus
• Non-healing wounds, ulcer or long bone fractures
• History of bleeding problems or coagulation problems
• History of abdominal fistula, gi perforation or intrabdominal abscess within 6 months
• History of uncontrolled hypertension

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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62 participants in 1 patient group

Treatment

Experimental group

Description:

Prior to surgery study treatment will be given over a 6 weeks (Days 1-42) period. Beginning Day 1 and continuing through Day 35 patients will receive a continuous infusion of 5-FU by vein. A small portable pump will be used to administer this drug into a tube that has been surgically inserted into the patient's vein. On Day 1 and 22 patients will also receive the drugs paclitaxel, carboplatin and bevacizumab by vein. Erlotinib is given by mouth beginning on Day 1 and continuing through Day 45. Patients will receive radiation therapy daily, Monday through Friday, beginning Day 1-35 (approximately 5 weeks). Surgery will be performed approximately 12-14 weeks after beginning this combined treatment.

Treatment:

Drug: 5-FU

Drug: Carboplatin

Procedure: Surgery

Drug: Bevacizumab

Procedure: Radiation therapy

Drug: Paclitaxel

Drug: Erlotinib